# K213024: Oren LED Perioral Light Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical CO, Ltd.
- Decided: Dec 22, 2021 after 92 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K101190 (2010). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172662: reVive Perioral, Led Technologies, Inc. (2018) Summary page 5.

## Most influential descendants
- K260202: LED Light Therapy Masks (LumiLips FAC07NA) (2026), 0 descendants of its own

## Indications for use
The Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.

Source page: https://510kreport.com/device/K213024
Methodology: https://510kreport.com/methodology